Summary of Product Characteristics (SmPC) - Benylin dry & Tickly Cough syrup
1 NAME OF THE MEDICINAL PRODUCT
Benylin Dry & Tickly Coughs Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient per 5 ml Glycerol 0.75 ml Sucrose 1.71g
Excipients with known effect:
Liquid Glucose 2.342g Propylene glycol (E1520) 24mg Sodium benzoate (E211) 10mg Ethanol 5mg Sodium 1.62mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the relief of irritating, tickling dry coughs and sore throats.
4.2 Posology and method of administration
Posology:
Adults and children over 5 years: 10 ml
Children 1 – 5 years: 5 ml
The dose may be repeated three or four times a day.
Children under one year: Not to be given to children under 1 year.
Elderly:
There is no need for dosage reduction in the elderly.
Method of administration:
For oral use.
4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Do not give to children under one year.
4.4 Special warnings and precautions for use
Diabetics should take note that sucrose and glycerol may affect blood sugar levels.
Information relating specifically to excipients in the formulation.
This medicine contains sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains 24 mg propylene glycol in each 5 ml which is equivalent to 4.8mg/ml.
This medicine contains 10 mg sodium benzoate (E211) in each 5ml.
This medicine contains 5 mg of alcohol (ethanol) in each 5 ml dose. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or wine. The small amount of alcohol in this medicine will not have any noticeable effects.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodium-free’.
If symptoms persist for more than 3 days or get worse, patients should stop use and consult a doctor.
4.5. Interactions with other medicinal products and other forms of Interaction
No clinically significant interactions known.
4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.
4.7. Effects on ability to drive and use machines
This medicine has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
No known adverse effects.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Management:
Overdosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Cough suppressants and mucolytics, ATC code: R05FB01
Glycerol and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors within the respiratory tract.
5.2 Pharmacokinetic properties
Absorption
Glycerol is readily absorbed from the gastrointestinal tract.
Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose which are then absorbed.
Distribution
Glycerol combines with free fatty acids in the liver to form triglycerides which are distributed to adipose tissues.
There are limited data on the distribution of oral sucrose in man.
Metabolism
Glycerol undergoes extensive metabolism principally in the liver and to a lesser extent in the kidneys. Glycerol is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. The hydrolysis products of sucrose are metaboliszed through different pathways in the body. Glucose elicits a glycaemic and insulinaemic response that stimulates its update into cells while fructose is mainly metaboliszed in the liver via an insulin-independent pathway not regulated by energy supply. Fructose may be converted into trioses that can be used for the de novo synthesis of triglycerides and cholesterol.
Elimination
It may also be excreted in the urine unchanged.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric acid monohydrate
Sodium benzoate (E211)
Cough syrup 513277 flavour (containing anise oil, liquorice, propylene glycol (E1520), ethanol (alcohol))
Black treacle
Liquid glucose
Purified water
6.2. Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
A white flint glass bottle with an aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.
Alternative cap: A wadless polypropylene tamper evident cap.
Pack size: 200 ml
Or
An amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal (LDPE/EPE/LDPE) liner.
Pack size: 125ml or 150ml
Or
An amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.
Alternative cap: An aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.
Pack size: 150ml or 300ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
McNeil Products
Limited 1 Station Hill
Square Station Hill
Reading
RG1 1LN
UK
8. MARKETING AUTHORISATION NUMBER(S)
PL 15513/0142
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11th January 2005
10 DATE OF REVISION OF THE TEXT
08/06/2026